FDA Okays Intranasal Migraine Medication

The US Food and Drug Administration (FDA) has approved a low-dose sumatriptan powder delivered intranasally for the treatment of migraine with or without aura in adult patients.

“Onzetra Xsail provides a new and much needed treatment option for what can be a debilitating condition for millions of people,” said Roger K. Cady, MD, co-founder and director, Headache Care Center, Springfield, Missouri.

The system allows the medication to be deposited deep into the nose, an area rich with blood vessels, said Dr. Cady. “By delivering the medication here, Onzetra Xsail provides targeted and efficient delivery with the potential for fast, consistent relief, while also limiting the amount of medicine that goes down the back of the throat.”

The system is activated by a user’s breath, the company, Avanir Pharmaceuticals, explained in the recent press release. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose.

As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing and reduce gastrointestinal absorption.

Stewart Tepper, MD, professor, neurology, Dartmouth Medical School said in a release while many acute migraine treatments are available, more than 70% of patients are not fully satisfied with their current migraine treatment. “Given this high dissatisfaction, there remains an unmet need to provide patients with fast-acting, well tolerated therapies that deliver consistent relief.”

The company expects to make the new product available in the coming months.

The product is not indicated for the prevention of migraine attacks. Its safety and effectiveness have not been established for the treatment of cluster headache.